NCT02403700

Brief Summary

Bone modeling after tooth extraction has a major consequence on implant therapy, in particular in the esthetic zone. In esthetic sites, no tissue loss should occur if an optimal esthetic outcome is expected. Recent experimental studies in dogs have shown that neither an immediate implant insertion nor ridge preservation techniques can prevent this bone modeling process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

March 19, 2015

Last Update Submit

March 25, 2015

Conditions

Dimensional Alterations

Keywords

bone remodelingbone resorptionthree-dimensional imagingclinical trialdental implantmaxillabone healing

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in bone loss

    Measured by segmented surface model superimpositions. Changes in bone loss between baseline and 8 week healing period using CBCT technology. From the Digital Imaging and Communications in Medicine (DICOM) files two surface mesh model were generated, which were superimposed and the changes were subsequently analyzed.

    2-, 4-, 6-, 8-weeks

  • Change from baseline in soft tissue loss

    Changes in soft tissue loss at baseline, 2-, 4-, 6- and 8 weeks were analyzed be dental impressions, which were superimposed as well and the changes were analyzed.

    2-, 4-, 6-, 8-weeks

Secondary Outcomes (1)

  • Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing.

    At baseline and 8-weeks

Study Arms (1)

All study participants

One group observation study

Device: Cone beam computed tomography (CBCT)

Interventions

Cone beam computed tomography (CBCT)DEVICE

Dimensional changes are documented over a healing period of 8-weeks following single tooth extraction. To document these changes over time, two methods will be applied. Firstly, two cone beam computed tomographies (CBCT) will be obtained, one directly after tooth extraction, the other one at 8 weeks of socket healing prior to implant placement. The two CBCT's will be analyzed with a novel software program (InVivo Dental). Secondly, consecutive impressions will be made at day 0 (day of extraction), day 14, 28, 42, and 56 to digitally produce virtual 3D study models. These models can be analyzed with another software program (Geomagic Studi 10) to document the variations of the soft tissue in the extraction site.

All study participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The group is selected from the referred patient pool. Age 18 or older. Absence of significant medical conditions. Sites with a need for single tooth extraction in the anterior maxilla.

You may qualify if:

  • Signed informed consent
  • Age 18 years or older
  • Absence of significant medical conditions
  • Patients with healthy or effectually treated periodontal conditions
  • Candidate for single tooth replacement in the anterior maxilla

You may not qualify if:

  • General contraindications for dental and/or surgical treatments
  • Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
  • Inflammatory and autoimmune disease of oral cavity
  • Uncontrolled diabetes
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Oral Sugery and Stomatology

University of Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (9)

  • Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

    PMID: 15691354RESULT

  • Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.

    PMID: 12956657RESULT

  • Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Tissue modeling following implant placement in fresh extraction sockets. Clin Oral Implants Res. 2006 Dec;17(6):615-24. doi: 10.1111/j.1600-0501.2006.01317.x.

    PMID: 17092218RESULT

  • Araujo MG, Lindhe J. Ridge alterations following tooth extraction with and without flap elevation: an experimental study in the dog. Clin Oral Implants Res. 2009 Jun;20(6):545-9. doi: 10.1111/j.1600-0501.2008.01703.x.

    PMID: 19515033RESULT

  • Januario AL, Duarte WR, Barriviera M, Mesti JC, Araujo MG, Lindhe J. Dimension of the facial bone wall in the anterior maxilla: a cone-beam computed tomography study. Clin Oral Implants Res. 2011 Oct;22(10):1168-1171. doi: 10.1111/j.1600-0501.2010.02086.x. Epub 2011 Feb 15.

    PMID: 21320168RESULT

  • Fickl S, Zuhr O, Wachtel H, Bolz W, Huerzeler M. Tissue alterations after tooth extraction with and without surgical trauma: a volumetric study in the beagle dog. J Clin Periodontol. 2008 Apr;35(4):356-63. doi: 10.1111/j.1600-051X.2008.01209.x.

    PMID: 18353082RESULT

  • Fickl S, Zuhr O, Wachtel H, Bolz W, Huerzeler MB. Hard tissue alterations after socket preservation: an experimental study in the beagle dog. Clin Oral Implants Res. 2008 Nov;19(11):1111-8. doi: 10.1111/j.1600-0501.2008.01575.x.

    PMID: 18983313RESULT

  • Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

    PMID: 12956475RESULT

  • Chappuis V, Engel O, Shahim K, Reyes M, Katsaros C, Buser D. Soft Tissue Alterations in Esthetic Postextraction Sites: A 3-Dimensional Analysis. J Dent Res. 2015 Sep;94(9 Suppl):187S-93S. doi: 10.1177/0022034515592869. Epub 2015 Jun 30.

    PMID: 26130259DERIVED

MeSH Terms

Conditions

Bone Resorption

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedTomography, X-RayRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography

Study Officials

  • Chappuis

    Dep. Oral surgery and Stomatology, University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 31, 2015

Study Start

October 1, 2009

Primary Completion

May 1, 2012

Study Completion

November 1, 2012

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

CH(1)